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Roxee Medication Guide

Gentamicin Sulfate

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Liquid (Solution) Multiple FDA sponsors Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:40 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:40 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Jun 1, 2026, 10:36 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Gentamicin Sulfate

Gentamicin Sulfate

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Gentamicin Sulfate

For treatment of external eye infections and inflammation in dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, wounds, lacerations, peritonitis). For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (pneumonitis pneumonia, upper respiratory tract infections), skin and soft tissue (wounds, lacerations, peritonitis), and as supportive therapy for secondary bacterial infections associated with panleucopenia. Species commonly shown: Both, Poults 1 to 3 Day Old, 1 day-old broiler chicks.

Generic name
Gentamicin Sulfate
Brand names
Garasol®, Gentamicin Sulfate Solution 100 mg/ml, Legacy Sterile Solution Gentamicin Sulfate Solution, Gentaglyde™ Solution
Manufacturer
Multiple FDA sponsors
Species
Both, Poults 1 to 3 Day Old, 1 day-old broiler chicks, Horse
Dosage forms
Liquid (Solution), Soluble Powder, Ointment, Injection
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Garasol® Gentamicin Sulfate Solution 100 mg/ml Legacy Sterile Solution Gentamicin Sulfate Solution Gentaglyde™ Solution Gentamex™ 100 GentaMax® 100 GentaPoult Genta-Ject® Gentamicin Sulfate Pig Pump Oral Solution GEN-GARD® Gentasol Vetro-Gen™ Veterinary Ophthalmic Ointment Gentamicin Piglet Injection Gentamicin Sulfate Solution GentaMed™-P GentaMed™ Gentamicin Sulfate Ophthalmic Solution
Dosage forms
Liquid (Solution) Soluble Powder Ointment Injection Ophthalmic Solution

Indications / Uses

For treatment of external eye infections and inflammation in dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, wounds, lacerations, peritonitis). For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (pneumonitis pneumonia, upper respiratory tract infections), skin and soft tissue (wounds, lacerations, peritonitis), and as supportive therapy for secondary bacterial infections associated with panleucopenia.

Warnings / Contraindications

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Vomiting, Deafness, Lack of efficacy (bacteria) - NOS, Lethargy (see also Central nervous system depression in Neurological).

FAQ

Both, Poults 1 to 3 Day Old, 1 day-old broiler chicks, Horse, Mares, Not For Food, Neonate or suckling, Weanling, Eggs, excluding eggs for human consumption, Dog, Cat, 1 to 3 days old, 1 day old chicks

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Soluble Powder, Ointment, Injection

Related Conditions

Conjunctivitis Metritis Pica Pneumonia (aspiration, bacterial, viral) Pyoderma (superficial/deep)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested
  • Not for use in horses intended for food
  • Hives (1 reports)
  • High pancreatic-specific lipase (1 reports)
  • Hepatomegaly (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Gentamicin Sulfate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-071623
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 23 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-071623
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-071623
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Hives (1 reports), High pancreatic-specific lipase (1 reports), Hepatomegaly (1 reports), Gall bladder & bile duct disorder NOS (1 reports), Fluid in abdomen NOS (1 reports)

Body systems represented Signal grouping

Digestive (5), Skin & allergy (3), Other (24)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (19 reports), Cat (13 reports)

Breed metadata in reports Metadata only

Retriever - Labrador (2), Domestic Shorthair (1), ['Retriever - Labrador', 'Dog (unknown)'] (1), Shepherd Dog - German (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Gentamicin Sulfate fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should b, Not for use in horses intended for food, Hives, High pancreatic-specific lipase, Hepatomegaly

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Gentamicin Sulfate brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-071623 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. EA · document · documents
  8. FONSI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 15, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested
  • Not for use in horses intended for food
  • Hives
  • High pancreatic-specific lipase
  • Hepatomegaly

Most reported reactions:

  • Hives (1 reports)
  • High pancreatic-specific lipase (1 reports)
  • Hepatomegaly (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
1 day old chicks, 1 day-old broiler chicks, 1 to 3 days old, Cat, Dog, Eggs, Horse, Neonate or suckling, Poults 1 to 3 Day Old, Weanling
Indication / use
For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.
Form / route / dose
Form: Injection, Liquid (Solution), Ointment, Ophthalmic Solution, Soluble Powder
Route: Immersion, Intramuscular, Intrauterine, Ophthalmic, Oral, Subcutaneous, Topical
Confirm product label and patient-specific plan.
Warnings
  • High: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal…
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA sponsors
Form: Injection, Liquid (Solution), Ointment, Ophthalmic Solution, Soluble Powder
Identifiers:
ANADA: 200023 ANADA: 200037 ANADA: 200102 ANADA: 200115 ANADA: 200137 ANADA: 200147 ANADA: 200174 ANADA: 200183 ANADA: 200185 ANADA: 200188 ANADA: 200190 ANADA: 200191 ANADA: 200229 ANADA: 200273 ANADA: 200283 ANADA: 200287 ANADA: 200388 ANADA: 200394 ANADA: 200395 ANADA: 200415
Source metadata:

Warnings / Contraindications

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
5
Matching reports
1
Active filters
1
Selected filters
Reaction: Abnormal ultrasound finding Clear
Reset
Drill into common report signals
Abnormal ultrasound finding (1) Death by euthanasia (1) Decreased red blood cell count (1) Elevated alanine aminotransferase (ALT) (1) Other (5) Effectiveness (2) Digestive (1) Skin & allergy (1)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-071623

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Dog (unknown)']
Size / weight
25-49 lb (17.69 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
VomitingNot eatingWeight lossIcterusLeucopenia NOSDecreased red blood cell countThrombocytopeniaElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)Elevated total bilirubinHigh pancreatic-specific lipaseUrinary incontinenceInfectious disease NOSOverdoseGall bladder & bile duct disorder NOSLymphopeniaNeutropeniaSplenomegalyLoose stoolPancreas disorderHepatomegalyDeath by euthanasiaHypoalbuminaemiaHypoproteinaemiaFluid in abdomen NOSElevated blood urea nitrogen (BUN)Elevated bile acidsAbnormal ultrasound findingElevated cholesterol (total)Enlarged lymph node (localised)Reduced globulinsMonocytopeniaEosinopeniaLiver nodules
Body systems
DigestiveOther
Outcomes
Euthanized

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
23
Species represented
2
Grouped by Body System
Digestive (5) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (3) · Hives, Facial swelling (possible allergy), Chewing - pruritus Other (24) · High pancreatic-specific lipase, Hepatomegaly, Head shake - ear disorder
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Skin & allergy 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Skin & allergy 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (19) Cat (13)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Cat Non-serious - 1
Skin & allergy Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Skin & allergy Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Digestive Cat Serious - 1
Other Dog Serious - 1
Digestive Cat Serious - 1
Other Dog Serious - 1
Skin & allergy Dog Non-serious - 1
Digestive Cat Serious - 1
Digestive Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

101-862 Official label / PI · EA 101-862 Official label / PI · FONSI Garasol® SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

2

SPL

18

FOI

35

101-862

Official label / PI · EA

Open original

101-862

Official label / PI · FONSI

Open original

Garasol®

SPL · SPL

Open original
FDA Structured Product Label

Garasol®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Intervet, Inc.
NADA
101-862
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous
Species
Poults 1 to 3 Day Old • 1 day-old broiler chicks
Composition / specifications
Each milliliter of sterile aqueous solution contains the equivalent of 50 or 100 milligrams of gentamicin.

Chickens (day-old)

Indication
For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.
Dosage
0.2 milligram of gentamicin per 0.2 milliliter dose, using a 50 milligram-per-milliliter solution diluted with sterile physiological saline to 1.0 milligram per milliliter. Administer aseptically injecting the diluted product subcutaneously in the neck.
Limitations
For use in day-old chickens only. Do not slaughter treated animals for food for at least 5 weeks after treatment.

Turkeys (1- to 3-day-old poults)

Indication

As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin sulfate.

Dosage
One milligram of gentamicin per poult, using a 5 milligram-per-milliliter solution. Administer subcutaneously in the neck.
Limitations
Injected poults must not be slaughtered for food for at least 9 weeks after treatment.

GentaPoult

SPL · SPL

Open original
FDA Structured Product Label

GentaPoult Genta-Ject®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-147
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous
Species
Poults 1 to 3 Day Old • 1 day-old broiler chicks
Composition / specifications
Each milliliter of sterile aqueous solution contains the equivalent of 100 milligrams of gentamicin.

Turkeys (1 to 3 day old poults)

Indication
As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin.
Dosage
One milligram of gentamicin per 0.2 milliliter dose, using the 50-100-milligrams-per-milliliter product diluted with sterile saline to a concentration of 5 milligrams-per-milliliter.
Limitations
For 1 to 3 day old turkey poults. Administer subcutaneously in the neck. Injected poults must not be slaughtered for food for at least 9 weeks after treatment.

Chickens (day-old)

Indication
For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.
Dosage
0.2 milligram of gentamicin per 0.2 milliliter dose, using a 50 milligram-per-milliliter solution diluted with sterile physiological saline to 1.0 milligram per milliliter.
Limitations
Do not slaughter treated animals for food for at least 5 weeks after treatment. Administer aseptically injecting the diluted product subcutaneously in the neck.

Genta-Ject®

SPL · SPL

Open original
FDA Structured Product Label

GentaPoult Genta-Ject®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-147
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous
Species
Poults 1 to 3 Day Old • 1 day-old broiler chicks
Composition / specifications
Each milliliter of sterile aqueous solution contains the equivalent of 100 milligrams of gentamicin.

Turkeys (1 to 3 day old poults)

Indication
As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin.
Dosage
One milligram of gentamicin per 0.2 milliliter dose, using the 50-100-milligrams-per-milliliter product diluted with sterile saline to a concentration of 5 milligrams-per-milliliter.
Limitations
For 1 to 3 day old turkey poults. Administer subcutaneously in the neck. Injected poults must not be slaughtered for food for at least 9 weeks after treatment.

Chickens (day-old)

Indication
For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.
Dosage
0.2 milligram of gentamicin per 0.2 milliliter dose, using a 50 milligram-per-milliliter solution diluted with sterile physiological saline to 1.0 milligram per milliliter.
Limitations
Do not slaughter treated animals for food for at least 5 weeks after treatment. Administer aseptically injecting the diluted product subcutaneously in the neck.

Gentamicin Sulfate Ophthalmic Solution

SPL · SPL

Open original
FDA Structured Product Label

Gentamicin Sulfate Ophthalmic Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Domes Pharma S.A.
ANADA
200-576
Status
RX
Form
Ophthalmic Solution
Route
Ophthalmic
Species
Dog • Cat
Composition / specifications
Gentamicin sulfate equivalent to 3.0 mg gentamicin per mL of solution

Label highlights

Indication
For the topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats
Dosage
Instill 1 or 2 drops into the conjunctival sac 2 to 4 times a day
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian

Gentasol

SPL · SPL

Open original
FDA Structured Product Label

Gentasol

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Med-Pharmex, Inc.
ANADA
200-191
Status
OTC
Form
Liquid (Solution)
Route
Immersion
Species
Eggs
Composition / specifications
Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base.

Turkey (eggs)

Indication
The drug is recommended as an aid in the reduction or elimination of the following microorganisms from turkey-hatching eggs: Arizona hinshawii (paracolon), Salmonella st. paul, and Mycoplasma meleagris.
Dosage
The drug is added to clean water to provide a dip solution with a gentamicin concentration of 250 to 1,000 parts per million. A concentration of 500 parts per million is recommended. Clean eggs should be held submerged in the gentamicin solution under a vacuum of about 27.5 to 38 centimeters of mercury for 5 minutes followed by additional soaking in gentamicin solution for approximately 10 minutes at atmospheric pressure. Eggs can also be treated by warming them for 3 to 4 hours at approximately 40 degrees F, keeping eggs submerged for 10- 15 minutes.
Limitations
For use in the dipping treatment of turkey-hatching eggs only. Eggs which have been dipped in the drug shall not be used for food.

GentaMed™-P

SPL · SPL

Open original
FDA Structured Product Label

GentaMed™-P

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Bimeda Animal Health Ltd.
ANADA
200-468
Status
RX
Form
Injection
Route
Subcutaneous
Species
Poults 1 to 3 Day Old • 1 day old chicks

Chickens

Indication

For the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.

Dosage
0.2 milligram of gentamicin per 0.2 milliliter dose.

Turkeys

Indication
As an aid in the prevention of early mortality of 1 to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.
Dosage
One (1) milligram of gentamicin per 0.2 milliliter dose.

Gentamicin Piglet Injection

SPL · SPL

Open original
FDA Structured Product Label

Gentamicin Piglet Injection

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Sparhawk Laboratories, Inc.
ANADA
200-394
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
1 to 3 days old
Composition / specifications
Each milliliter of sterile aqueous solution contains the equivalent of 5 milligrams of gentamicin.

Swine

Indication
In piglets up to 3 days old for treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin
Dosage
5 milligrams of gentamicin as a single intramuscular dose using 5 milligram-per-milliliter solution.
Limitations
For single intramuscular dose in pigs up to 3 days of age only. Do not slaughter treated animals for food for at least 40 days following treatment

Gentamicin Sulfate Pig Pump Oral Solution

SPL · SPL

Open original
FDA Structured Product Label

Gentamicin Sulfate Pig Pump Oral Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-174
Status
RX
Form
Liquid (Solution)
Route
Oral
Species
Neonate or suckling
Composition / specifications
Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 5 milligrams of gentamicin.

Swine (neonatal, 1 to 3 days of age)

Indication

For the control and treatment of colibacillosis in neonatal pigs 1-3 days of age, caused by strains of E. coli sensitive to gentamicin.

Dosage

Administer 1 mL of pig pump oral solution (5 mg of gentamicin) orally per pig one time.


Vetro-Gen™ Veterinary Ophthalmic Ointment

SPL · SPL

Open original
FDA Structured Product Label

Vetro-Gen™ Veterinary Ophthalmic Ointment

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Dechra Veterinary Products LLC
ANADA
200-273
Status
OTC
Form
Ointment
Route
Topical
Species
Dog • Cat
Composition / specifications
Each gram of sterile ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

Dogs

Indication
The drug is used for topical treatment of conjunctivitis caused by susceptible bacteria.
Dosage
Apply approximately a 1/2 inch strip to the affected eye 2 to 4 times a day.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication
The drug is used for topical treatment of conjunctivitis caused by susceptible bacteria.
Dosage
Apply approximately a 1/2 inch strip to the affected eye 2 to 4 times a day.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

GentaMed™

SPL · SPL

Open original
FDA Structured Product Label

GentaMed™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Bimeda Animal Health Ltd.
ANADA
200-494
Status
RX
Form
Soluble Powder
Route
Oral
Composition / specifications
Each gram of gentamicin sulfate soluble powder contains gentamicin sulfate equivalent to 333.3 milligrams of gentamicin. 120 grams of gentamicin per 360 gram jar.

Swine (weanling)

Indication

For the control and treatment of colibacillosis in weaning swine caused by strains of Escherichia coli sensitive to gentamicin.

Dosage

25 mg gentamicin per gallon (1 level scoop/240 gallons) of drinking water, for three consecutive days to provide 0.5 mg/lb/day. (Note: the jar contains a scoop that provides approximately 18 g of product when level full.) For proportioner use, add 1 level scoop to 2 gallons stock solution and dispense at the rate of 1 oz/gal drinking water (25 mg/gal).

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Swine

Indication

For the control and treatment of swine dysentery associated with Treponema hyodysenteriae.

Dosage

50 mg gentamicin per gallon (1 level scoop/120 gallons) for three consecutive days to ensure a gentamicin dosage of approximately 1.0 mg/lb/day. (Note: the jar contains a scoop that provides approximately 18 g of product when level full.)

For proportioner use, add 1 level scoop to 1 gallons stock solution and dispense at the rate of 1 oz/gal drinking water (50 mg/gal).

Limitations

For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Gentamex™ 100

SPL · SPL

Open original
FDA Structured Product Label

Gentamex™ 100

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Bimeda Animal Health Ltd.
ANADA
200-115
Status
RX
Form
Liquid (Solution)
Route
Intrauterine
Species
Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

GEN-GARD®

SPL · SPL

Open original
FDA Structured Product Label

GEN-GARD®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-185
Status
RX
Form
Soluble Powder
Route
Oral
Species
Weanling
Composition / specifications
Each gram of gentamicin sulfate soluble powder contains gentamicin sulfate equivalent to 333.3 milligrams of gentamicin.

Swine (weanling)

Indication

For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin.

Dosage

Administer gentamicin sulfate equivalent to 25 milligrams of gentamicin per gallon of drinking water to provide 0.5 milligram per pound of body weight per day for 3 consecutive days.

Limitations

For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Do not slaughter treated swine for food for at least 10 days following treatment. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Swine

Indication

For control and treatment of swine dysentery associated with Brachyspira hyodysenteriae.

Dosage

Administer gentamicin sulfate equivalent to 50 milligrams of gentamicin per gallon of drinking water to provide 1.0 milligram per pound of body weight per day for 3 consecutive days. Treatment may be repeated if dysentery recurs.

Limitations

For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Do not slaughter treated swine for food for at least 10 days following treatment. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Legacy Sterile Solution

SPL · SPL

Open original
FDA Structured Product Label

Legacy Sterile Solution Gentamicin Sulfate Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-037
Status
RX
Form
Liquid (Solution)
Route
Intrauterine
Species
Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

Gentamicin Sulfate Solution

SPL · SPL

Open original
FDA Structured Product Label

Legacy Sterile Solution Gentamicin Sulfate Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Huvepharma EOOD
ANADA
200-037
Status
RX
Form
Liquid (Solution)
Route
Intrauterine
Species
Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

GentaMax® 100

SPL · SPL

Open original
FDA Structured Product Label

GentaMax® 100

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
ANADA
200-137
Status
RX
Form
Liquid (Solution)
Route
Intrauterine
Species
Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

Gentamicin Sulfate Solution 100 mg/ml

SPL · SPL

Open original
FDA Structured Product Label

Gentamicin Sulfate Solution 100 mg/ml

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-023
Status
RX
Form
Liquid (Solution)
Route
Intrauterine
Species
Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption

Gentaglyde™ Solution

SPL · SPL

Open original
FDA Structured Product Label

Gentaglyde™ Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
ANADA
200-102
Status
RX
Form
Liquid (Solution)
Route
Intrauterine
Species
Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses

Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

Gentamicin Sulfate Solution

SPL · SPL

Open original
FDA Structured Product Label

Gentamicin Sulfate Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Sparhawk Laboratories, Inc.
ANADA
200-395
Status
RX
Form
Liquid (Solution)
Route
Intrauterine
Species
Horse
Composition / specifications
Each milliliter of the drug contains 50 or 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses

Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption

N101862_Supp_3_28_1996(2).pdf

FOI · FOI

Open original

ucm061600.pdf

FOI · FOI

Open original

A200147_Orig_4_10_1995.pdf

FOI · FOI

Open original

UCM433786.pdf

FOI · FOI

Open original

A200191_Org_3_24_1997.pdf

FOI · FOI

Open original

UCM396874.pdf

FOI · FOI

Open original

ucm061343.pdf

FOI · FOI

Open original

A200174_Org_4_10_1997.pdf

FOI · FOI

Open original

ucm061701.pdf

FOI · FOI

Open original

UCM292012.pdf

FOI · FOI

Open original

A200115_Orig_7_21_1995.pdf

FOI · FOI

Open original

A200185_Org_4_30_1997.pdf

FOI · FOI

Open original

A200037_Org_2_8_1993.pdf

FOI · FOI

Open original

A200137_Orig_11_13_1996.pdf

FOI · FOI

Open original

A200023_Org_8_4_1995.pdf

FOI · FOI

Open original

A200102_Orig_05_19_1994.pdf

FOI · FOI

Open original

ucm061346.pdf

FOI · FOI

Open original

A200229_Orig_4_4_1998.pdf

FOI · FOI summary

Open original

UCM061643.pdf

FOI · FOI summary

Open original

A200188_Org_1_29_97.pdf

FOI · FOI summary

Open original

A200183_Org_7_31_1995.pdf

FOI · FOI summary

Open original

ucm117265.pdf

FOI · FOI summary

Open original

ucm117268.pdf

FOI · FOI summary

Open original

ucm117269.pdf

FOI · FOI summary

Open original

UCM287927.pdf

FOI · FOI summary

Open original

UCM167677.pdf

FOI · FOI summary

Open original

N140896_Org_6_9_1993.pdf

FOI · FOI summary

Open original

UCM504539.pdf

FOI · FOI summary

Open original

UCM292007.pdf

FOI · FOI summary

Open original

ucm061352.pdf

FOI · FOI summary

Open original

ucm061714.pdf

FOI · FOI summary

Open original

ucm061715.pdf

FOI · FOI summary

Open original

ucm061716.pdf

FOI · FOI summary

Open original

ucm061711.pdf

FOI · FOI summary

Open original

UCM436590.pdf

FOI · FOI summary

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: 1 day old chicks, 1 day-old broiler chicks, 1 to 3 days old, Cat, Dog, Eggs, Horse, Neonate or suckling, Poults 1 to 3 Day Old, Weanling
Rx/OTC: OTC, RX
Form/route: Injection, Liquid (Solution), Ointment, Ophthalmic Solution, Soluble Powder • Immersion, Intramuscular, Intrauterine, Ophthalmic, Oral, Subcutaneous, Topical
Applications: NADA 101-862 • ANADA 200-147 • ANADA 200-576 • ANADA 200-191 • ANADA 200-468 • ANADA 200-394 • ANADA 200-174 • ANADA 200-273 • ANADA 200-494 • ANADA 200-115 • ANADA 200-185 • ANADA 200-037 • ANADA 200-137 • ANADA 200-023 • ANADA 200-102 • ANADA 200-395
Documents: 19 (FOI: 17) • SPL: 18 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 50 • Cat 2 • View
Case summaries: 5 (showing 5) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: H60.90
Otitis externa, unspecified ear

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Hives (1) High pancreatic-specific lipase (1) Hepatomegaly (1) Gall bladder & bile duct disorder NOS (1) Fluid in abdomen NOS (1) Facial swelling (possible allergy) (1) Eosinopenia (1) Enlarged lymph node (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200023 ANADA: 200037 ANADA: 200102 ANADA: 200115 ANADA: 200137 ANADA: 200147 ANADA: 200174 ANADA: 200183 ANADA: 200185 ANADA: 200188 ANADA: 200190 ANADA: 200191 ANADA: 200229 ANADA: 200273 ANADA: 200283 ANADA: 200287 ANADA: 200388 ANADA: 200394 ANADA: 200395 ANADA: 200415 ANADA: 200416 ANADA: 200468 ANADA: 200494 ANADA: 200536
Package NDC Product NDC Form / Route Status
0061-0100-01 0061 -
0061-0134-01 0061 -
0061-0387-01 0061 -
0061-0387-02 0061 -
0061-0387-03 0061 -
0061-0387-08 0061 -
0061-0387-17 0061 -
0061-1246-01 0061 -
0061-1246-02 0061 -
0061-1246-04 0061 -
0061-1246-05 0061 -
11695-4153-1 11695 -
11695-4153-2 11695 -
11695-7009-1 11695 -
11695-7009-2 11695 -
11695-7009-3 11695 -
13985-566-12 13985 -
13985-566-24 13985 -
13985-566-60 13985 -
13985-701-07 13985 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • A200229_Orig_4_4_1998.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200229
  • UCM061643.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200229
  • A200188_Org_1_29_97.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200188
  • A200183_Org_7_31_1995.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200183
  • N101862_Supp_3_28_1996(2).pdf • FOI summary • Official • Feb. 3, 2026
    FDA FOI summary for application 101862
  • ucm117265.pdf • FOI summary • Official • Dec. 3, 2025
    FDA FOI summary for application 141177
  • ucm117268.pdf • FOI summary • Official • Dec. 3, 2025
    FDA FOI summary for application 141177
  • ucm117269.pdf • FOI summary • Official • Dec. 3, 2025
    FDA FOI summary for application 141177
  • A200147_Orig_4_10_1995.pdf • FOI summary • Official • July 3, 2024
    FDA FOI summary for application 200147
  • ucm061600.pdf • FOI summary • Official • July 3, 2024
    FDA FOI summary for application 200147
  • UCM287927.pdf • FOI summary • Official • May 14, 2024
    FDA FOI summary for application 141330
  • UCM433786.pdf • FOI summary • Official • Dec. 14, 2023
    FDA FOI summary for application 200576
  • A200191_Org_3_24_1997.pdf • FOI summary • Official • Aug. 25, 2023
    FDA FOI summary for application 200191
  • UCM396874.pdf • FOI summary • Official • April 26, 2023
    FDA FOI summary for application 200468
  • ucm061343.pdf • FOI summary • Official • April 26, 2023
    FDA FOI summary for application 200394
  • A200174_Org_4_10_1997.pdf • FOI summary • Official • April 26, 2023
    FDA FOI summary for application 200174
  • ucm061701.pdf • FOI summary • Official • Oct. 1, 2019
    FDA FOI summary for application 200273
  • UCM167677.pdf • FOI summary • Official • Oct. 1, 2019
    FDA FOI summary for application 200388
  • UCM292012.pdf • FOI summary • Official • Oct. 2, 2018
    FDA FOI summary for application 200494
  • A200115_Orig_7_21_1995.pdf • FOI summary • Official • Oct. 2, 2018
    FDA FOI summary for application 200115
  • A200185_Org_4_30_1997.pdf • FOI summary • Official • July 2, 2018
    FDA FOI summary for application 200185
  • A200037_Org_2_8_1993.pdf • FOI summary • Official • July 2, 2018
    FDA FOI summary for application 200037
  • A200137_Orig_11_13_1996.pdf • FOI summary • Official • June 19, 2018
    FDA FOI summary for application 200137
  • A200023_Org_8_4_1995.pdf • FOI summary • Official • Feb. 1, 2018
    FDA FOI summary for application 200023
  • A200102_Orig_05_19_1994.pdf • FOI summary • Official • July 19, 2017
    FDA FOI summary for application 200102
  • N140896_Org_6_9_1993.pdf • FOI summary • Official • May 17, 2017
    FDA FOI summary for application 140896
  • UCM504539.pdf • FOI summary • Official • Aug. 16, 2016
    FDA FOI summary for application 200536
  • ucm061346.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200395
  • UCM292007.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200416
  • ucm061352.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200415
  • ucm061714.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200287
  • ucm061715.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200287
  • ucm061716.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200287
  • ucm061711.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200283
  • UCM436590.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 34267

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 106 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on… (Clinical, 2026-04-16)
  • contraindications: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on… (Clinical, 2026-04-15)
  • contraindications: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on… (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Vomiting, Deafness, Lack of efficacy (bacteria) - NOS, Lethargy (see also Central ne… (Clinical, 2026-04-11)
  • usage: For treatment of external eye infections and inflammation in dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (t… (Clinical, 2026-04-16)
  • usage: For treatment of external eye infections and inflammation in dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (t… (Clinical, 2026-04-15)
  • usage: For treatment of external eye infections and inflammation in dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (t… (Clinical, 2026-04-11)
  • contraindications: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on… (Official, 2026-04-22)
  • contraindications: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on… (Official, 2026-02-12)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-22)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-22)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-21)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-20)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-13)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-12)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-12)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-11)
  • indications: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonel… (Official, 2026-06-11)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 13:29 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:29 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:29 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:29 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:29 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:29 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Garasol®
RX
Gentamicin Sulfate
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Intervet, Inc. NADA 101-862 Approved Feb 3, 2026
GentaPoult Genta-Ject®
RX
Gentamicin Sulfate
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Huvepharma EOOD ANADA 200-147 Approved Jul 3, 2024
Gentamicin Sulfate Ophthalmic Solution
RX
Gentamicin Sulfate
Ophthalmic Solution • Ophthalmic
Label highlights
Official documents
Domes Pharma S.A. ANADA 200-576 Approved Dec 14, 2023
Gentasol
OTC
Gentamicin Sulfate
Liquid (Solution) • Immersion
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-191 W Aug 25, 2023
GentaMed™-P
RX
Gentamicin Sulfate
Injection • Subcutaneous
Label highlights
Official documents
Bimeda Animal Health Ltd. ANADA 200-468 Approved Apr 26, 2023
Gentamicin Piglet Injection
RX
Gentamicin Sulfate
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Sparhawk Laboratories, Inc. ANADA 200-394 Approved Apr 26, 2023
Gentamicin Sulfate Pig Pump Oral Solution
RX
Gentamicin Sulfate
Liquid (Solution) • Oral
Label highlights
Official documents
Huvepharma EOOD ANADA 200-174 Approved Apr 26, 2023
Vetro-Gen™ Veterinary Ophthalmic Ointment
OTC
Gentamicin Sulfate
Ointment • Topical
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-273 Approved Oct 1, 2019
GentaMed™
RX
Gentamicin Sulfate
Soluble Powder • Oral
Label highlights
Official documents
Bimeda Animal Health Ltd. ANADA 200-494 Approved Oct 2, 2018
Gentamex™ 100
RX
Gentamicin Sulfate
Liquid (Solution) • Intrauterine
Label highlights
Official documents
Bimeda Animal Health Ltd. ANADA 200-115 Approved Oct 2, 2018
GEN-GARD®
RX
Gentamicin Sulfate
Soluble Powder • Oral
Label highlights
Official documents
Huvepharma EOOD ANADA 200-185 Approved Jul 2, 2018
Legacy Sterile Solution Gentamicin Sulfate Solution
RX
Gentamicin Sulfate
Liquid (Solution) • Intrauterine
Label highlights
Official documents
Huvepharma EOOD ANADA 200-037 Approved Jul 2, 2018
GentaMax® 100
RX
Gentamicin Sulfate
Liquid (Solution) • Intrauterine
Label highlights
Official documents
Elanco US Inc. ANADA 200-137 Approved Jun 19, 2018
Gentamicin Sulfate Solution 100 mg/ml
RX
Gentamicin Sulfate
Liquid (Solution) • Intrauterine
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-023 Approved Feb 1, 2018
Gentaglyde™ Solution
RX
Gentamicin Sulfate
Liquid (Solution) • Intrauterine
Label highlights
Official documents
Zoetis Inc. ANADA 200-102 Approved Jul 19, 2017
Gentamicin Sulfate Solution
RX
Gentamicin Sulfate
Liquid (Solution) • Intrauterine
Label highlights
Official documents
Sparhawk Laboratories, Inc. ANADA 200-395 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Poults 1 to 3 Day Old • 1 day-old broiler chicks
Composition / specifications
Each milliliter of sterile aqueous solution contains the equivalent of 50 or 100 milligrams of gentamicin.
Chickens (day-old)
Indication
For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.
Dosage
0.2 milligram of gentamicin per 0.2 milliliter dose, using a 50 milligram-per-milliliter solution diluted with sterile physiological saline to 1.0 milligram per milliliter. Administer aseptically injecting the diluted product subcutaneously in the neck.
Limitations
For use in day-old chickens only. Do not slaughter treated animals for food for at least 5 weeks after treatment.
Turkeys (1- to 3-day-old poults)
Indication

As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin sulfate.

Dosage
One milligram of gentamicin per poult, using a 5 milligram-per-milliliter solution. Administer subcutaneously in the neck.
Limitations
Injected poults must not be slaughtered for food for at least 9 weeks after treatment.

FDA page: Open in Animal Drugs @ FDA

Species: Poults 1 to 3 Day Old • 1 day-old broiler chicks
Composition / specifications
Each milliliter of sterile aqueous solution contains the equivalent of 100 milligrams of gentamicin.
Turkeys (1 to 3 day old poults)
Indication
As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin.
Dosage
One milligram of gentamicin per 0.2 milliliter dose, using the 50-100-milligrams-per-milliliter product diluted with sterile saline to a concentration of 5 milligrams-per-milliliter.
Limitations
For 1 to 3 day old turkey poults. Administer subcutaneously in the neck. Injected poults must not be slaughtered for food for at least 9 weeks after treatment.
Chickens (day-old)
Indication
For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.
Dosage
0.2 milligram of gentamicin per 0.2 milliliter dose, using a 50 milligram-per-milliliter solution diluted with sterile physiological saline to 1.0 milligram per milliliter.
Limitations
Do not slaughter treated animals for food for at least 5 weeks after treatment. Administer aseptically injecting the diluted product subcutaneously in the neck.

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Cat
Composition / specifications
Gentamicin sulfate equivalent to 3.0 mg gentamicin per mL of solution
Label highlights
Indication
For the topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats
Dosage
Instill 1 or 2 drops into the conjunctival sac 2 to 4 times a day
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian

FDA page: Open in Animal Drugs @ FDA

Species: Eggs
Composition / specifications
Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base.
Turkey (eggs)
Indication
The drug is recommended as an aid in the reduction or elimination of the following microorganisms from turkey-hatching eggs: Arizona hinshawii (paracolon), Salmonella st. paul, and Mycoplasma meleagris.
Dosage
The drug is added to clean water to provide a dip solution with a gentamicin concentration of 250 to 1,000 parts per million. A concentration of 500 parts per million is recommended. Clean eggs should be held submerged in the gentamicin solution under a vacuum of about 27.5 to 38 centimeters of mercury for 5 minutes followed by additional soaking in gentamicin solution for approximately 10 minutes at atmospheric pressure. Eggs can also be treated by warming them for 3 to 4 hours at approximately 40 degrees F, keeping eggs submerged for 10- 15 minutes.
Limitations
For use in the dipping treatment of turkey-hatching eggs only. Eggs which have been dipped in the drug shall not be used for food.

FDA page: Open in Animal Drugs @ FDA

Species: Poults 1 to 3 Day Old • 1 day old chicks
Chickens
Indication

For the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.

Dosage
0.2 milligram of gentamicin per 0.2 milliliter dose.
Limitations
Turkeys
Indication
As an aid in the prevention of early mortality of 1 to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.
Dosage
One (1) milligram of gentamicin per 0.2 milliliter dose.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: 1 to 3 days old
Composition / specifications
Each milliliter of sterile aqueous solution contains the equivalent of 5 milligrams of gentamicin.
Swine
Indication
In piglets up to 3 days old for treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin
Dosage
5 milligrams of gentamicin as a single intramuscular dose using 5 milligram-per-milliliter solution.
Limitations
For single intramuscular dose in pigs up to 3 days of age only. Do not slaughter treated animals for food for at least 40 days following treatment

FDA page: Open in Animal Drugs @ FDA

Species: Neonate or suckling
Composition / specifications
Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 5 milligrams of gentamicin.
Swine (neonatal, 1 to 3 days of age)
Indication

For the control and treatment of colibacillosis in neonatal pigs 1-3 days of age, caused by strains of E. coli sensitive to gentamicin.

Dosage

Administer 1 mL of pig pump oral solution (5 mg of gentamicin) orally per pig one time.


Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Cat
Composition / specifications
Each gram of sterile ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.
Dogs
Indication
The drug is used for topical treatment of conjunctivitis caused by susceptible bacteria.
Dosage
Apply approximately a 1/2 inch strip to the affected eye 2 to 4 times a day.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats
Indication
The drug is used for topical treatment of conjunctivitis caused by susceptible bacteria.
Dosage
Apply approximately a 1/2 inch strip to the affected eye 2 to 4 times a day.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
Each gram of gentamicin sulfate soluble powder contains gentamicin sulfate equivalent to 333.3 milligrams of gentamicin. 120 grams of gentamicin per 360 gram jar.
Swine (weanling)
Indication

For the control and treatment of colibacillosis in weaning swine caused by strains of Escherichia coli sensitive to gentamicin.

Dosage

25 mg gentamicin per gallon (1 level scoop/240 gallons) of drinking water, for three consecutive days to provide 0.5 mg/lb/day. (Note: the jar contains a scoop that provides approximately 18 g of product when level full.) For proportioner use, add 1 level scoop to 2 gallons stock solution and dispense at the rate of 1 oz/gal drinking water (25 mg/gal).

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Swine
Indication

For the control and treatment of swine dysentery associated with Treponema hyodysenteriae.

Dosage

50 mg gentamicin per gallon (1 level scoop/120 gallons) for three consecutive days to ensure a gentamicin dosage of approximately 1.0 mg/lb/day. (Note: the jar contains a scoop that provides approximately 18 g of product when level full.)

For proportioner use, add 1 level scoop to 1 gallons stock solution and dispense at the rate of 1 oz/gal drinking water (50 mg/gal).

Limitations

For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
Horses (mares)
Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Weanling
Composition / specifications
Each gram of gentamicin sulfate soluble powder contains gentamicin sulfate equivalent to 333.3 milligrams of gentamicin.
Swine (weanling)
Indication

For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin.

Dosage

Administer gentamicin sulfate equivalent to 25 milligrams of gentamicin per gallon of drinking water to provide 0.5 milligram per pound of body weight per day for 3 consecutive days.

Limitations

For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Do not slaughter treated swine for food for at least 10 days following treatment. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Swine
Indication

For control and treatment of swine dysentery associated with Brachyspira hyodysenteriae.

Dosage

Administer gentamicin sulfate equivalent to 50 milligrams of gentamicin per gallon of drinking water to provide 1.0 milligram per pound of body weight per day for 3 consecutive days. Treatment may be repeated if dysentery recurs.

Limitations

For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Do not slaughter treated swine for food for at least 10 days following treatment. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
Horses (mares)
Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
Horses (mares)
Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
Horses (mares)
Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
Horses
Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Horse
Composition / specifications
Each milliliter of the drug contains 50 or 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
Horses
Indication
The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Dosage
It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption

FDA page: Open in Animal Drugs @ FDA

Usage

For treatment of external eye infections and inflammation in dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, wounds, lacerations, peritonitis). For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (pneumonitis pneumonia, upper respiratory tract infections), skin and soft tissue (wounds, lacerations, peritonitis), and as supportive therapy for secondary bacterial infections associated with panleucopenia.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Cat Diarrhea (1) • Cat Decreased appetite (1) • Cat Bloody diarrhoea (1) • Cat Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Hives (1) • Dog Facial swelling (possible allergy) (1) • Dog Chewing - pruritus (1) • Dog

Showing top 5 for Skin & allergy.

Other
High pancreatic-specific lipase (1) • Dog Hepatomegaly (1) • Dog Head shake - ear disorder (1) • Dog Glucosuria (1) • Cat Gall bladder & bile duct disorder NOS (1) • Dog
Show more (19)
Fluid in abdomen NOS (1) • Dog Eosinopenia (1) • Dog Enlarged lymph node (1) • Dog Elevated total bilirubin (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated globulins (1) • Cat Elevated cholesterol (1) • Dog Elevated blood urea nitrogen (1) • Cat Elevated bile acids (1) • Dog Elevated alanine aminotransferase (1) • Cat Ear pain (1) • Cat Ear infection NOS (1) • Cat Ear canal inflammation (1) • Dog Decreased red blood cell count (1) • Dog Death by euthanasia (1) • Dog Application site scratching (1) • Dog Administration error NOS (1) • Cat Abscess NOS (1) • Cat Abnormal ultrasound finding (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, Domestic Shorthair, Male, 7.07 year, 6.26 kilogram • Drug: MSK, Topical • Reactions: Other abnormal test result NOS, Lack of efficacy - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-071515
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 7.07 Year
  • Weight: 6.260 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
Reactions Reported:
Other abnormal test result NOS Lack of efficacy - NOS
Outcomes: Ongoing

Dog, ['Retriever - Labrador', 'Dog (unknown)'], Male, 12 year, 17.69 kilogram • Drug: MSK, Unassigned, Topical • Reactions: Vomiting, Not eating, Weight loss, Icterus, Leucopenia NOS… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-071623
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 17.690 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Unassigned
Reactions Reported:
Vomiting Not eating Weight loss Icterus Leucopenia NOS Decreased red blood cell count Thrombocytopenia Elevated alanine aminotransferase Elevated serum alkaline phosphatase Elevated total bilirubin High pancreatic-specific lipase Urinary incontinence Infectious disease NOS Overdose Gall bladder & bile duct disorder NOS Lymphopenia Neutropenia Splenomegaly Loose stool Pancreas disorder Hepatomegaly Death by euthanasia Hypoalbuminaemia Hypoproteinaemia Fluid in abdomen NOS Elevated blood urea nitrogen Elevated bile acids Abnormal ultrasound finding Elevated cholesterol Enlarged lymph node Reduced globulins Monocytopenia Eosinopenia Liver nodules
Outcomes: Euthanized

Dog, Retriever - Labrador, Female, 8.75 year, 30.11 kilogram • Drug: MSK, Unknown • Reactions: Lying down, Sedation, Tongue protrusion • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-068370
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 8.75 Year
  • Weight: 30.110 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lying down Sedation Tongue protrusion
Outcomes: Ongoing

Dog, Shepherd Dog - German, Female, 4 year, 27.66 kilogram • Drug: MSK, Spray, Unknown • Reactions: Licking at injection site, Injection site pain, Injection site lump, Injection site erythema, Injection site alopecia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-063395
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 27.660 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Spray
Reactions Reported:
Licking at injection site Injection site pain Injection site lump Injection site erythema Injection site alopecia Lameness Injection site crust Injection site abscess Injection site reaction NOS
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 2.5 year, 45.359 kilogram • Drug: MSK, Auricular (Otic) • Reactions: Head shake - ear disorder, Lack of efficacy (bacteria) - Ehrlichia, Obesity/adipositas, Lack of efficacy (endoparasite) - heartworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-062121
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 2.50 Year
  • Weight: 45.359 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
Reactions Reported:
Head shake - ear disorder Lack of efficacy (bacteria) - Ehrlichia Obesity/adipositas Lack of efficacy (endoparasite) - heartworm
Outcomes: Outcome Unknown

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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